Safety iv catheter with v-clip interlock and needle tip capture

ABSTRACT

A catheter assembly ( 10 ) comprises a catheter ( 22 ), a needle ( 12 ) having a sharp distal tip, a catheter hub ( 14 ) housing the catheter ( 22 ), the catheter hub ( 14 ) having a collar ( 34 ) including a notch ( 36 ), a needle shield ( 20 ) connected to the catheter hub ( 14 ) when the needle ( 12 ) is in a first position, and a clip ( 40 ) disposed in the needle shield ( 20 ) that cooperates with the needle ( 12 ), wherein the clip ( 40 ) engages the catheter hub ( 14 ) in the first position of the needle ( 12 ), and the clip ( 40 ) disengages the catheter hub ( 14 ) via the notch ( 36 ) when the needle ( 12 ) is retracted to a second position to cover at least a portion of the needle ( 12 ). The clip ( 40 ) is mounted in the outer housing ( 38 ) of the needle shield ( 20 ) via a spade ( 66 ) having an outer wall ( 70 ) exposed to the outside of the needle shield ( 20 ), in order to reduce the overall width of the needle shield ( 20 ).

RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication Ser. No. 62/077,760, filed on Nov. 10, 2014, InternationalPatent Application No. PCT/US2015/026542, filed Apr. 17, 2015, and U.S.Provisional Patent Application Ser. No. 62/220,629, filed on Sep. 18,2015. Each of the foregoing applications is hereby incorporated byreference in its entirety.

FIELD

Various exemplary embodiments of the invention relate to catheters.

BACKGROUND

Catheter assemblies are used to place a catheter into the vascularsystem of a patient. Once in place, catheters such as intravenouscatheters may be used to infuse fluids including normal saline,medicinal compounds, and/or nutritional compositions into a patient inneed of such treatment. Catheters additionally enable the removal offluids from the circulatory system and monitoring of conditions withinthe vascular system of the patient.

SUMMARY OF THE INVENTION

It is an aspect of the present invention to provide a catheter assemblyin which an improved clip and needle shield are used for needleprotection. The improved arrangement is more compact, provides increasedneedle protection, and reduces the size and complexity of the catheterassembly. The improved clip provides a more narrow design, increasedstrength and flexibility, and a variety of mounting configurations tosecure the clip to the needle shield. The addition of a release notch ina collar of a catheter hub and disengagement of the clip via the notchallows the needle shield to be more compact than in the prior art. Inthe prior art, without the notch, the clip has to travel a longerdistance to disengage the catheter hub. In addition, the width of theneedle shield is reduced by an improved attachment interface between theclip and the needle shield. Specifically, a spade attaches the clip tothe needle shield with an outer surface of the spade exposed to anoutside of the needle shield.

The foregoing and/or other aspects of the present invention can beachieved by providing a catheter assembly comprising a catheter, aneedle having a sharp distal tip disposed in the catheter, a catheterhub housing the catheter and the needle, the catheter hub having anotch, a needle shield connected to the catheter hub when the needle isin a first position, and a clip disposed in the needle shield thatcooperates with the needle, wherein the clip engages the collar in thefirst position of the needle, the clip disengages the collar via thenotch when the needle is retracted to a second position to enclose orcover at least a portion of the needle.

The foregoing and/or other aspects of the present invention can beachieved by also providing a catheter assembly comprising a catheter, aneedle having a sharp distal tip disposed in the catheter, a catheterhub housing the catheter and the needle, a needle shield configured tobe connected to the catheter hub, and a clip disposed in the needleshield that cooperates with the needle, the clip including a spade thatattaches the clip to the needle shield, wherein an outer surface of thespade is exposed to an outside of the catheter assembly.

BRIEF DESCRIPTION OF THE DRAWINGS

The above aspects and features of the present invention will be moreapparent from the description for the exemplary embodiments of thepresent invention taken with reference to the accompanying drawings, inwhich:

FIG. 1 illustrates a top left perspective view of a catheter assembly inaccordance with an embodiment of the present invention;

FIG. 2 illustrates a side left perspective view of a catheter assembly;

FIG. 3 illustrates an alternate side left perspective view of a catheterassembly;

FIG. 4 illustrates a top plan view of the catheter assembly;

FIG. 5 illustrates a right side elevation view of the catheter assembly;

FIG. 6 illustrates a bottom plan view of the catheter assembly;

FIG. 7 illustrates a left perspective view of the assembled catheterhub, needle shield, and needle of the catheter assembly;

FIG. 8 illustrates a right perspective view of the assembled catheterhub, needle shield, and needle of the catheter assembly;

FIG. 9 illustrates a right side elevation view of the assembled catheterhub, needle shield, and needle of the catheter assembly;

FIG. 10 illustrates a bottom plan view of the assembled catheter hub,needle shield, and needle of the catheter assembly;

FIG. 11 illustrates a bottom plan view of the assembled catheter hub,needle shield, and needle of the catheter assembly;

FIG. 12 illustrates a top plan view of the assembled catheter hub,needle shield, and needle of the catheter assembly;

FIG. 13 illustrates a cross sectional view of a right side elevationview of the assembled catheter hub, needle shield, and needle of thecatheter assembly;

FIG. 14 illustrates a left perspective view of the separated catheterhub, needle shield, and needle of the catheter assembly;

FIG. 15 illustrates a right perspective view of the separated catheterhub, needle shield, and needle of the catheter assembly;

FIG. 16 illustrates a right side elevation view of the separatedcatheter hub, needle shield, and needle of the catheter assembly;

FIG. 17 illustrates a second right side elevation view of the separatedcatheter hub, needle shield, and needle of the catheter assembly;

FIG. 18 illustrates a bottom plan view of the separated catheter hub,needle shield, and needle of the catheter assembly;

FIG. 19 illustrates a top plan view of the separated catheter hub,needle shield, and needle of the catheter assembly;

FIG. 20 illustrates a cross sectional view of a right side elevationview of the separated catheter hub, needle shield, and needle of thecatheter assembly;

FIG. 21 is a right perspective view of the catheter hub of the catheterassembly;

FIG. 22 is a top plan view of the catheter hub of the catheter assembly;

FIG. 23 is a left perspective view of the catheter hub of the catheterassembly;

FIG. 24 is a front side view of the catheter hub of the catheterassembly;

FIG. 25 is a right side view of the catheter hub of the catheterassembly;

FIG. 26 is a rear side view of the catheter hub of the catheterassembly;

FIG. 27 is a left perspective view of the catheter hub of the catheterassembly;

FIG. 28 is a bottom plan view of the catheter hub of the catheterassembly;

FIG. 29 is a right perspective view of the catheter hub of the catheterassembly;

FIG. 30 illustrates a right perspective view of the needle shield outerhousing of the catheter assembly;

FIG. 31 illustrates a left perspective view of the needle shield outerhousing of the catheter assembly;

FIG. 32 illustrates a second left perspective view of the needle shieldouter housing of the catheter assembly;

FIG. 33 illustrates a second right perspective view of the needle shieldouter housing of the catheter assembly;

FIG. 34 illustrates a front side elevation view of the needle shieldouter housing of the catheter assembly;

FIG. 35 illustrates a rear side elevation view of the needle shieldouter housing of the catheter assembly;

FIG. 36 illustrates a right side elevation view of the needle shieldouter housing of the catheter assembly;

FIG. 37 illustrates a right side elevation view of the needle shieldouter housing of the catheter assembly;

FIG. 38 illustrates a top plan view of the needle shield outer housingof the catheter assembly;

FIG. 39 illustrates a bottom plan view of the needle shield outerhousing of the catheter assembly;

FIG. 40 illustrates a left perspective view of the V-shaped metal clipof the catheter assembly;

FIG. 41 illustrates a right perspective view of the V-shaped metal clipof the catheter assembly;

FIG. 42 illustrates a second right perspective view of the V-shapedmetal clip of the catheter assembly;

FIG. 43 illustrates a front elevation view of the V-shaped metal clip ofthe catheter assembly;

FIG. 44 illustrates a rear elevation view of the V-shaped metal clip ofthe catheter assembly;

FIG. 45 illustrates a left side elevation view of the V-shaped metalclip of the catheter assembly;

FIG. 46 illustrates a right side elevation view of the V-shaped metalclip of the catheter assembly;

FIG. 47 illustrates a top plan view of the V-shaped metal clip of thecatheter assembly;

FIG. 48 illustrates a bottom plan view of the V-shaped metal clip of thecatheter assembly;

FIG. 49 illustrates a right perspective view of an alternate embodimentof the V-shaped metal clip of the catheter assembly;

FIG. 50 illustrates a right perspective view of an alternate embodimentof the V-shaped metal clip of the catheter assembly;

FIG. 51 illustrates a left perspective view of an alternate embodimentof the V-shaped metal clip of the catheter assembly;

FIG. 52 illustrates a left perspective view of the V-shaped metal clipof FIG. 51 inserted into a needle shield;

FIG. 53 illustrates a right perspective view of an alternate embodimentof the V-shaped metal clip of the catheter assembly;

FIG. 54 illustrates a right perspective view of the V-shaped metal clipof FIG. 53 inserted into a needle shield;

FIG. 55 illustrates a left perspective view of an alternate embodimentof the V-shaped metal clip of the catheter assembly;

FIG. 56 illustrates a right perspective view of an alternate embodimentof the V-shaped metal clip of the catheter assembly;

FIG. 57 illustrates a right perspective view of an alternate embodimentof the V-shaped metal clip of the catheter assembly;

FIG. 58 illustrates a right perspective view of the V-shaped metal clipof FIG. 57 inserted into a needle shield;

FIG. 59 illustrates a right perspective view of an alternate embodimentof the V-shaped metal clip of the catheter assembly;

FIG. 60 illustrates a left perspective view of the V-shaped metal clipof FIG. 59 inserted into a needle shield;

FIG. 61 illustrates a left, rear perspective view of an alternateembodiment of the V-shaped metal clip of the catheter assembly;

FIG. 62 illustrates a left, bottom perspective view of the V-shapedmetal clip of FIG. 61 of the catheter assembly;

FIG. 63 illustrates a top view of the V-shaped metal clip of FIG. 61 ofthe catheter assembly;

FIG. 64 illustrates a side cross sectional view of the V-shaped metalclip of FIG. 61 in a first and second state disposed in a needle shield;

FIG. 65 illustrates a left, rear perspective view of the V-shaped metalclip of FIG. 61 inserted into a needle shield;

FIG. 66 illustrates a right perspective view of an alternate embodimentof the V-shaped metal clip of the catheter assembly;

FIG. 67 illustrates a right perspective view of an alternate embodimentof the V-shaped metal clip of the catheter assembly;

FIG. 68 illustrates a right perspective view of an alternate embodimentof the V-shaped metal clip of the catheter assembly;

FIG. 69 illustrates a front cross sectional view of an alternateembodiment of the V-shaped metal clip of the catheter assembly;

FIG. 70 illustrates a right perspective view of an alternate embodimentof the V-shaped metal clip of the catheter assembly;

FIG. 71 illustrates a right perspective view of an alternate embodimentof the V-shaped metal clip of the catheter assembly;

FIG. 72 illustrates a right perspective view of an alternate embodimentof the V-shaped metal clip of the catheter assembly;

FIG. 73 illustrates another right perspective view of the V-shaped metalclip of FIG. 72 of the catheter assembly;

FIG. 74 illustrates a left perspective view of an alternate embodimentof the V-shaped metal clip of the catheter assembly;

FIG. 75 illustrates a right, rear perspective view of an alternateembodiment of the V-shaped metal clip of the catheter assembly;

FIG. 76 illustrates a right perspective view of the washer of thecatheter assembly;

FIG. 77 illustrates a left perspective view of the washer of thecatheter assembly;

FIG. 78 illustrates a front elevation view of the washer of the catheterassembly;

FIG. 79 illustrates a bottom plan view of the washer of the catheterassembly;

FIG. 80 illustrates a cross sectional view of a left side elevation viewof the washer of the catheter assembly;

FIG. 81 illustrates a right perspective view of an alternative catheterhub with wings;

FIG. 82 illustrates a top plan view of the catheter hub with wings;

FIG. 83 illustrates a left perspective view of the catheter hub withwings;

FIG. 84 illustrates a front view of the catheter hub with wings;

FIG. 85 illustrates a left side elevation view of the catheter hub withwings;

FIG. 86 illustrates a rear elevation view of the catheter hub withwings;

FIG. 87 illustrates a left perspective view of the catheter hub withwings;

FIG. 88 illustrates a bottom plan view of the catheter hub with wings;

FIG. 89 illustrates a second right perspective view of the catheter hubwith wings;

FIG. 90 illustrates a right perspective view of an alternative side portcatheter hub;

FIG. 91 illustrates a top plan view of the side port catheter hub;

FIG. 92 illustrates a left perspective view of the side port catheterhub;

FIG. 93 illustrates a front elevation view of the side port catheterhub;

FIG. 94 illustrates a right side elevation view of the side portcatheter hub;

FIG. 95 illustrates a rear elevation view of the side port catheter hub;

FIG. 96 illustrates a second left perspective view of the side portcatheter hub;

FIG. 97 illustrates a bottom plan view of the side port catheter hub;

FIG. 98 illustrates a second right perspective view of the side portcatheter hub;

FIG. 99 illustrates a left perspective view of the alternative side portcatheter hub assembly with a needle shield and needle hub;

FIG. 100 illustrates a right perspective view of the alternative sideport catheter hub assembly with a needle shield and needle hub;

FIG. 101 illustrates a top plan view of the alternative side portcatheter hub assembly with a needle shield and needle hub;

FIG. 102 illustrates a right side view of the alternative side portcatheter hub assembly with a needle shield and needle hub;

FIG. 103 illustrates a bottom plan view of the alternative side portcatheter hub assembly with a needle shield and needle hub;

FIG. 104 illustrates a cross sectional view of the catheter assembly ofFIGS. 1-12 as the introducer needle is being withdrawn;

FIG. 105 illustrates a second cross sectional view of the catheterassembly of FIGS. 1-12 as the introducer needle is being withdrawn;

FIG. 106 illustrates a cross sectional view of the catheter assembly ofFIGS. 1-16 as the introducer needle is moved past the V-shaped metalclip and the needle shield is separated from the catheter hub;

FIG. 107 illustrates a second cross sectional view of the catheterassembly of FIGS. 1-16 as the introducer needle is moved past theV-shaped metal clip and the needle shield is separated from the catheterhub;

FIG. 108 illustrates a latch of the V-shaped metal clip engaged with thecatheter hub;

FIG. 109 illustrates the latch of the V-shaped metal clip disengagedfrom the catheter hub;

FIG. 110 illustrates the latch of the V-shaped metal clip disengagedfrom the catheter hub and separated;

FIG. 111 illustrates a view of the V-shaped metal clip blocking theneedle;

FIG. 112 illustrates a view of the V-shaped metal clip in the closedposition;

FIG. 113 illustrates a schematic view of the working envelope of theV-shaped metal clip and catheter hub collar without a notch;

FIG. 114 illustrates a schematic view of the working envelope of theV-shaped metal clip and catheter hub collar without the notch;

FIG. 115 illustrates a schematic view of the working envelope of theV-shaped metal clip and notched catheter hub collar;

FIG. 116 illustrates a schematic view of the working envelope of theV-shaped metal clip and notched catheter hub collar;

FIG. 117 illustrates the operation of the catheter hub valve actuator ina free state;

FIG. 118 illustrates the operation of the catheter hub valve actuator ina compressed state;

FIG. 119 illustrates the operation of a second embodiment of a catheterhub valve actuator in a free state;

FIG. 120 illustrates the operation of the second embodiment of thecatheter hub valve actuator in the compressed state;

FIG. 121 illustrates another embodiment of the catheter hub valveactuator;

FIG. 122 illustrates an exemplary blood flashback feature of thecatheter assembly;

FIG. 123 illustrates the needle of the blood flashback feature of thecatheter assembly of FIG. 122;

FIG. 124 illustrates a second exemplary blood flashback feature of thecatheter assembly;

FIG. 125 illustrates the second exemplary blood flashback feature of thecatheter assembly of FIG. 124 with blood flashback in two places;

FIG. 126 illustrates a third exemplary blood flashback features of thecatheter assembly with blood flashback in three places;

FIG. 127 illustrates a right side view of the exemplary embodiment ofthe actuator of FIG. 121;

FIG. 128 illustrates a cross sectional view of the actuator of FIG. 127in a catheter hub assembly;

FIG. 129 illustrates the cross sectional view of the catheter hubassembly of FIG. 128 when penetrating a septum;

FIG. 130 illustrates a left perspective cross sectional view of thecatheter hub assembly of FIG. 128 when penetrating a septum;

FIG. 131 illustrates a cross sectional view of another exemplaryembodiment of a catheter hub assembly;

FIG. 132 illustrates the cross sectional view of the catheter hubassembly of FIG. 131 when penetrating a septum; and

FIG. 133 illustrates a left perspective cross sectional view of thecatheter hub assembly of FIG. 131 when penetrating a septum.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

The catheter assembly disclosed herein is an improvement over thatdisclosed in commonly owned U.S. Patent Application Publication No.2014/0364809, which is incorporated herein by reference.

FIGS. 1-12 illustrate a catheter assembly 10 includes a hollow metalintroducer needle 12, a catheter hub 14, a needle hub 16, and a needleshield 20. The needle 12 has a sharpened and beveled distal end andinitially extends through the needle shield 20 and the catheter hub 14.A flexible catheter tube 22 extends from the distal end of the catheterhub 14, with the introducer needle 12 passing through the catheter tube22. Initially, the needle 12 is inserted into a patient's vein. Thecatheter tube 22 is carried by the needle 12 into the vein. After thecatheter tube 22 is inserted, the needle 12 is removed from thepatient's vein and the catheter hub 14. The needle shield 20 encloses orcovers the tip of the needle 12 and provides protection from being stuckby the needle 12 during and after the needle's retraction from thecatheter hub 14. The needle shield 20 can be used with a variety ofdifferent catheters.

As illustrated in FIGS. 12-20, the catheter assembly includes thecatheter hub 14 and the flexible catheter tube 22 extending from thecatheter hub 14. A metal wedge 24 is positioned in the catheter hub 14to retain the catheter tube 22. A resilient septum 26 is positioned tocontrol fluid flow through the catheter hub 14. An actuator 28 ismoveably positioned in the catheter hub 14 to engage the septum 26. Abiasing member 30 engages the actuator 28 to bias the actuator 28 in theproximal direction.

The resilient septum 26 has one or more pre-formed slits which arenormally closed to selectively prevent unwanted fluid flow through theseptum 26. For example, the septum 26 can have three slits forming threetriangular flaps that open when engaged by the actuator 28. The septum26 is made from an elastic material, for example silicone rubber, thatprovides the resilient closing force for the slits. Other septum 26configurations may be used as would be understood by one of ordinaryskill in the art.

The actuator 28 and the biasing member 30, for example a metal orplastic compression spring, are positioned in the catheter hub 14. Theactuator 28 engages the septum 26 to open the slits and permit fluidflow through the catheter hub 14. The biasing member 30 is capable ofreturning the actuator 28 to a position that allows the slits to close,preventing fluid flow through the catheter hub 14.

As best shown in the exemplary embodiment of FIGS. 21-29, the catheterhub 14 includes a proximal end having external Luer thread 32 and anotched collar 34. The collar 34 extends around at least a portion ofthe catheter hub 14 and is preferably disposed at a proximal end of thecatheter hub 14. The collar 34 has a break, opening or notch 36separating first and second ends of the collar 34.

A portion of the collar 34 includes an outer diameter that is greaterthan a portion of an outer diameter of the catheter hub 14 adjacent tothe collar 34. Specifically, a portion of the outer diameter of thecollar 34 is elevated with respect to the adjacent outer diametersurface of the catheter hub 14. Additionally, the opening 36 of thecollar 34 has an outer diameter substantially equal to or greater than aportion of an outer diameter of the catheter hub 14 adjacent to thecollar 34.

In an exemplary embodiment, the needle shield 20 includes an outerhousing 38, a resilient clip 40, and a washer 42. The outer housing 38includes an aperture having a distal opening 44 and a proximal opening46 to receive the needle 12. The outer housing 38 connects to thecatheter hub 14 and surrounds the clip 40 and the washer 42. As bestshown in FIGS. 30-39, the distal end of the outer housing 38 includes anose 48, a top flange 50, and a base 52. When the needle shield 20 isconnected to the catheter hub 14, the nose 48 extends into the interiorof the catheter hub 14.

In an exemplary embodiment, the nose 48 is sized to be slightly smallerthan the interior of the catheter hub 14 so as to fit with a loosetolerance. The top flange 50 is spaced from the base 52 by a pair ofside recesses that receive the Luer threads 32 and prevent rotation ofthe catheter hub 14 with respect to the needle shield 20 when assembled.The base 52 includes a projection 54 having a curved top surface andcurved cut-out portion 56. The projection 54 is sized to fit in theopening 36 of the collar 34 and the cut-out portion 56 is sized to allowthe collar 34 to pass therethrough.

According to an exemplary embodiment illustrated in FIGS. 40-48, theclip 40 is a substantially V-shaped resilient clip 40 having a first leg60 and a second leg 62 connected by an angled or curved V section 64.The first leg 60 includes a substantially U-shaped spade 66 having anangled lead-in portion 68. The spade 66 includes an outer wall 70 and aninner wall 72 connected by a bottom 74. A pair of barbs 76 extendsoutwardly from the inner wall 72 of the spade 66. A first flag 78extends from the second leg 62 toward the first leg 60 and a second flag80 extends from the first leg 60 toward the second leg 62. A foot 82extends outwardly from the first flag 78 away from the first and secondlegs 60, 62, and a latch 84 extends upwardly from the foot 84 and ispositioned between the first and second legs 60, 62. Specifically, thelatch 84 is disposed between a plane representing the first leg 60 and aplane representing the second let 62. Such a configuration is desired tocreate a more compact clip 40. An optional stiffener 86 can extenddownwardly from the foot 82.

FIGS. 49-75 illustrate alternate embodiments of the clip 710 that havesimilar features to the preferred embodiment of clip 40 in FIGS. 40-48as described above. The details of the alternate embodiments of the clip710, specifically the features that distinguish from the clip 40 inFIGS. 40-48, are described below. For brevity, the explanation of thesimilar features of the clip in FIGS. 40-75 is not repeated but ratherunderstood by one skilled in the art base on the prior descriptionherein. The features of the exemplary embodiments of FIGS. 49-75 may becombined with features of the other exemplary embodiments disclosedherein as appropriate.

FIG. 49 illustrates an alternate embodiment of a clip 710 having asubstantially V shape with a first leg 712 and a second leg 714connected by a curved section 716. The second leg 714 includes a spade718. The spade 718 includes an outer wall 720 connected to the secondleg 714 by a bottom portion 724. An inner wall of the spade 718 is notpresent in this embodiment because the second leg 714 is fully extendedto the top of the spade 718. Thus, the spade 718 does not have asubstantially U shape. A pair of barbs 726 (only one is visiblyillustrated) extends outwardly from the outer wall 720 of the spade 718.

FIG. 49 further illustrates a foot 732 extends outwardly and away fromthe first and second legs 712, 714 and a latch 734 extends upwardly fromthe foot 732. The latch 734 is positioned outside an area between thefirst and second legs 712, 714. Specifically, the latch 734 is disposedoutside of an area between a plane representing the first leg 712 and aplane representing the second leg 714. A rib 736 extends downwardly fromthe foot 732 to stiffen and strengthen the clip 710.

FIG. 50 illustrates an alternate embodiment of a clip 710 including aU-shaped spade 718 having an outer wall 720 and an inner wall 722. Thespade 718 is located on a bottom portion of the outer and inner walls720, 722. The inner wall 722 reduces the length of the second leg 714but the inner wall 722 includes barbs 726 that secure the clip 710 tothe needle shield. Moving the barbs 726 from the outer wall 720 to theinner wall 722 advantageously makes the clip 710 narrower. Specifically,an outer wall of the needle shield can be removed while still adequatelysecuring the clip 710. Additionally, the clip 710 includes a foot 732and a latch 734 that are disposed between the first and second legs 712,714. In other words, the foot 732 and latch 734 are positioned between aplane representing the first leg 712 and a plane representing the secondleg 714.

FIGS. 51 and 52 illustrate an alternate embodiment of a clip 710 havinga longer second leg 714 that is exposed to the outside of the needleshield 750. Specifically, the needle shield 750 is covered by the needlehub, so that the clip 710 is not exposed to the outside environment,just to the outside of the needle shield 750. The spade 718 is disposedbetween a plane representing the first leg 712 and a plane representingthe second leg 714 making the clip 710 even narrower. Barbs (notillustrated) can also be present at the inner wall 722 of the spade 718to secure the clip 710.

According to another alternate embodiment of the clip 710 of FIG. 51,the curved section 716 between the first and second legs 712, 714 can bea flat surface. In this manner, the spade 718 can pinch or draw the flatsurface and the bottom portion 724 together. Such a design can provideincreased retention of the clip 710.

The longer second leg 714 has several advantages. A longer spring legcreates a more flexible V shaped spring where the spring force is moreevenly applied across the length of the second leg 714. Additionally, amore flexible clip 710 reduces the stiffness and the internal stresswhile improving the overall life of the spring. However, in thisinstance, an opening 752 in the needle shield 750 for the clip 710 forassembly access and operation reduces the stiffness and overall strengthof the needle shield 750.

FIGS. 53 and 54 illustrate an alternate embodiment of a clip 710 havinga longer second leg 714 with the advantages described above. The outerwall 720 of the spade 718 extends further upward to cover the modifiedopening 752 of the needle shield 750 upon assembly. Accordingly, such adesign can block debris or blood from entering the clip 710 and theneedle shield 750 and protect the catheter assembly from the outsideenvironment.

The clip 710 includes a first flag 728 and a second flag 730. The firstflag 728 is directly connected to the first leg 712 and the foot 732 tofor the following advantages. The flag design improves the overallstrength of the clip 710, eases manufacturability, creates a morecompact design and reduces metal scrap. On the other hand, the secondflag 730 is directly connected to only the second leg 714. The two flags728, 730 cooperate together to block the opening of the needle shieldwhen the needle is in a retracted position inside the needle shield.

The spade 718 is not U shaped. Rather, the outer wall 720 is bent inwardon both sides of the second leg 714 and then bent outward and away fromeach side of the second leg 714. Thus, the inner wall 722 issubstantially parallel to the outer wall 720 but the inner wall 722 isnot directly connected to the width of the second leg 714. On the otherhand, the inner wall 722 is present adjacent to a front and rear planeof the second leg 714. Slots 754 in the needle shield 750 engage thebarbs 726 and the inner wall 722 to secure the clip 710.

Although the needle shield 750 in this embodiment is stronger than inthe embodiment of FIG. 52, the modified opening 752 still weakens theneedle shield 750. Also, the clip 710 includes additional bends andincreased complexity that pose challenges during manufacturing.

FIG. 55 illustrates an alternate embodiment of a clip 710 including arib 736 on the outer wall 720 and a rib 736 on the foot 732. When thebarbs 726 of the outer wall 720 of the spade 718 engage an outer wall ofthe needle shield, a counteracting resistance force is applied to theclip 710. Depending on the amount of counteracting force applied, theclip 710 at the spade 718 could plastically deform or even fail. It ispreferred that the clip 710 at the spade 718 only experience elasticdeformation to maintain an appropriate spring life.

The rib 736 acts as a stiffener to increase the strength of the clip 710and reduce the likelihood of the clip 710 to permanently bend or buckle.The clip 710 also includes a flag 728. The flag 728 is directlyconnected to the first leg 712 only. Thus, there is a gap between theflag 728 and the foot 732 to advantageously aid for the purposes oftooling in manufacturability, forming and assembly.

FIG. 56 illustrates an alternate embodiment of a clip 710 including aspade 718 that only has an inner wall 722. The spade 718 does not havean outer wall that goes around the wall of the needle shield. The innerwall 722 includes a barb 726 that engages the needle shield when theclip 710 is assembled. Although only a single barb 726 is illustrated,another barb is contemplated on the other side of the second leg 714. Aspring force in the clip 710 applies a force to secure the barb 726 ofthe spade 718 to the needle shield. This clip 710 configurationadvantageously provides a narrower design because the clip 710 does notwrap around the outside of the needle shield. Accordingly, this designmay also improve assembly.

The clip 710 also includes a flag 728. The flag 728 is directlyconnected to the first leg 712 and the foot 732. This clip 710 designadvantageously improves the stamping operation during manufacturing bycreating a more compact design and reducing the amount of scrap.

FIGS. 57 and 58 illustrate an alternate embodiment of a clip 710including a spade 718 disposed on a top surface of the outer wall 720.The spade 718 includes an outer wall 720 and barbs 726 to secure theclip 710 to the needle shield 750. The outer wall 720 is connected tothe second leg 714 via the bottom portion 724 of the spade 718. Thisconfiguration of the clip 710 includes long spring legs for both thefirst and second legs 712, 714. The long spring legs provide theadvantages of reduced stress and increased flexibility as describedabove.

FIGS. 59 and 60 illustrate an alternate embodiment of a clip 710 thatdoes not have a spade to mount to the needle shield 50. Instead, thesecond leg 714 bends approximately 180 degrees (corresponds to a foldedsurface) at a bottom surface to form a ledge 723 on both sides of thesecond leg 714, an inner wall 722 and barbs 726 (on both sides, notillustrated).

When the clip 710 is assembled, the ledge 723 is disposed on a bottomsurface of the needle shield 750. The inner wall 722 and barbs 726engage an inner cavity of the needle shield 750 to secure the clip 710.This configuration allows the second leg 714 to have a longer length toachieve the advantages described above. However, the 180 degree bend cancreate high stress during manufacturing and in operation.

FIGS. 61-65 illustrate an alternate embodiment of a clip 710 in theneedle shield 750. FIG. 61 illustrates the clip 710 including a longsecond leg 714 with a bend at a lowermost portion to form a ledge 723.The second leg 714 includes similar benefits as described above withrespect to its extended length. Additionally, the clip 710 includes amounting cavity 738 to engage and secure the clip 710 to the needleshield (as further described below).

FIGS. 61 and 62 illustrate a foot 732 and a latch 734 on a bottomportion of the clip 710. A flag 728 is directly connected to the secondleg 714. The clip 710 further includes barbs 726 attached to the ledge723 at approximately a 90 degrees angle. The barbs 726 secure the clip710 to the needle shield 750 (as further described below).

FIG. 63 illustrates a top view of the clip 710 that shows how the clip710 is assembled into the needle shield. Specifically, the user appliespressure to outside surfaces of the first and second legs 712, 714 tocompress them toward each other. More specifically, the user can holdthe clip 710 at an outer surface of the foot 732 and an outer surface ofthe ledge 723 (see arrows indicating grasping locations) and pull thesetwo surfaces together to initiate assembly. Such a configuration aids inthe assembly of the clip 710 into the needle shield.

FIG. 64 illustrates the clip 710 mounted into the needle shield 750. Theclip 710 is illustrated in two states. The first state is the compressedstate, where the clip 710 is compressed to aid assembly into the needleshield 750. Additionally, the first state illustrates the conditionwhere the needle of the needle shield 750 is in operation. Duringoperation, the first leg 712 contacts the needle (not shown). In thefirst state, the mounting cavity 738 is not engaged to the mountingprotrusion 756 of the needle shield 750.

In the second state, when the needle is retracted and the needle tipenters into the needle shield 750, the needle no longer contacts thefirst leg 712 (not shown) and the clip 710 is released. As a result, themounting cavity 738 of the clip 710 engages a mounting protrusion 756 inthe needle shield 750. Additionally, the flag 728 blocks the needle fromexiting the needle shield 750.

Accordingly, the engagement between the mounting cavity 738 and themounting protrusion 756 advantageously prevents the clip 710 from beingaccidentally released from the needle shield 750. The engagement alsoadvantageously prevents undesired movement of the clip 710 in the needleshield 750 and tampering of the clip 710 by an unauthorized person.

FIG. 65 illustrates the clip 710 assembled in the needle shield 750. Theneedle shield 750 includes a housing slot 754 that receives the barbs726 of the clip 710. The ledge 723 is disposed on a bottom surface ofthe needle shield 750. Engagement of the barbs 726 in the housing slot754 advantageously prevents the clip 710 from moving upward and exitingthe needle shield 750. Additionally, the barbs 726 of the clip 710replace the need for a spade that goes around the outer wall of theneedle shield 750 to secure the clip 710. Accordingly, the width of theclip 710 and the needle shield assembly is reduced.

FIG. 66 illustrates an alternate embodiment of a clip 710 including afront wall 742 and a rear wall 740. The front and rear walls 742, 740are perpendicular to a longitudinal axis of a needle in the needleshield (not shown). Specifically, an outer wall 720 of the spade 718 isbent approximately 90 degrees inward on each side of the second leg 714toward the longitudinal axis of the needle. The front and rear walls742, 740 includes holes 743 to allow the needle to pass through duringoperation. Barbs 726 are disposed on each of the rear and front walls740, 742 for appropriate mounting into the needle shield.

FIG. 67 illustrates an alternate embodiment of a clip 710 similar to theembodiment of FIG. 66. The clip 710 includes a rear wall 740 but doesnot include a front wall 742. Specifically, an upper portion of thesecond leg 714 is bent inward at approximately 80 degrees into a topwall 744. The rear end of the top wall 744 is bent downwardly atapproximately 90 degrees to form a rear wall 740. A barb 726 is disposedon the rear wall 740 to securely mount to the needle shield.

FIG. 68 illustrates an alternate embodiment of a clip 710 that acts asan extension spring instead of a compression spring. In all of the otherembodiments of the clip described herein, the needle compresses the clipduring operation (like a compression spring). When the needle is removedand enters into the needle shield, the clip releases and blocks theneedle from exiting (release of the compression spring).

According to this embodiment, however, the clip 710 includes a firstintermediate leg 746 and a second intermediate leg 748 disposed betweenthe first leg 712 and the second leg 714. The first and second legs 712,714 are attached to opposing surfaces of the needle shield.

When the needle is in operation, the needle contacts the secondintermediate leg 748 causing the clip 710 to be in an extended position.Such a position causes the second intermediate leg 748 to act as anextension spring. Specifically, the second intermediate leg 748naturally tends to move toward the first leg 712 but the needle preventsthat from occurring.

When the needle is retracted into the needle shield, the secondintermediate leg 748 is released and moves toward the first leg 712 (theextension spring returns to a normal position). Accordingly, the flag728 moves in front of the needle and blocks the needle from exiting theneedle shield.

FIG. 69 illustrates an alternate embodiment of a clip 710 including anouter wall 720 of the spade 718 having an opening 727. The opening 727receives a mounting protrusion 756 of the needle shield 750 when theclip 710 is assembled. Such a configuration advantageously providesanother simple manner to mount and secure the clip 710 to the needleshield 750.

According to an alternate embodiment of the clip 710 of FIG. 69, theouter wall 720 can include two barbs disposed perpendicular andextending away from the outer wall 720. The two barbs pinch or latchonto an inner rib or an inner wall of the needle shield. Such a featureadvantageously allows the clip 710 to be reliably retained whileminimizing the overall width of the clip 710.

FIG. 70 illustrates an alternate embodiment of a clip 710 including amodified spade 718. Specifically, the spade 718 includes an outer wall720 with barbs 726 and an inner wall 722 with a flap 725. The barbs 726and flap 725 can also respectively be switched and disposed on oppositewalls 720, 722 of the spade 718. When the clip 710 is mounted into theneedle shield, the barbs 726 and the flap 725 each contact a side of awall of the needle shield to secure the clip 710. In other words, thecontact between the barbs 726 and the flap 725 pinch and fix the clip710 to the needle shield.

FIG. 71 illustrates an alternate embodiment of a clip 710 similar toFIG. 70 where the outer and inner walls 720, 722 are extended in awidthwise direction of the clip 710. Specifically, the outer and innerwalls 720, 722 are extended beyond the width of the second leg 714 onboth sides to advantageously provide a larger surface are to secure theclip 710. Although not illustrated, the outer and inner walls 720, 722can include barbs 726 and flaps 725, as described in FIG. 70.

FIGS. 72 and 73 illustrate an alternate embodiment of a clip 710including a shorter second leg 714. A bend is disposed between thesecond leg 714 and the inner wall 722 of the spade 718 causing thesecond leg 714 to be shorter. As a result, the second leg 714advantageously provides a stiffer and stronger clip 710.

FIG. 74 illustrates an alternate embodiment of a clip 710 including afoot 732 and latch 734 being disposed between the first and second legs712, 714. The foot 732 includes a rib 736 to provide improved stiffnessand strength. Additionally, the flag 728 is directly connected to thefirst leg 712. The flag 28 is not directly connected to the foot 732 andlatch 734. The design of the clip 710 where the flag 728 attaches onlyto the first leg 712 advantageously provides extra space for toolingduring manufacturing and improves assembly.

FIG. 75 illustrates an alternate embodiment of a clip 710 including asecond leg 714 having a ledge 723 at a top portion of the second leg714. The second leg 714 further includes a rear wall 740 disposed belowthe ledge 723. The rear wall 740 bends approximately 90 degrees inwardtoward the first leg 712. The rear wall 740 includes barbs 726 thatmount on to the needle shield to secure the clip 710.

Referring to the earlier drawings, the clip 40 of FIGS. 40-48 isconnected to the outer housing 38 with the spade 66 being positionedaround an exterior wall of the outer housing 38. The spade 66 isattached to the exterior wall of the outer housing 38 so that the outerwall 70 of the spade 66 is exposed to the outside of the needle shield20. This configuration advantageously reduces the width of the needleshield 20, compared to an arrangement wherein the spade 66 is receivedwithin an internal cavity of the outer housing 38 such that the outerwall 70 is not exposed to the outside of the outer housing 38. As bestshown in FIGS. 106-112, the inner wall 72 of the spade 66 is positionedin a recess and the two barbs 76 extend away from the inner wall 72 toengage a pair of projections 89 in the needle shield 20. The two barbs76 aid in securely fastening the clip 40 to an inner surface of theneedle shield 20. The clip 40 may be formed from a metal, elastomer,polymer, or composite material. In various exemplary embodiments, theclip 40 is formed from a thin piece of resilient metal, such asstainless steel.

According to an exemplary embodiment illustrated in FIGS. 76-80, thewasher 42 includes a base 88 and a side wall 90 connected together in asubstantially L-shape. The side wall 90 includes a funnel 92 and anopening 94. The needle 12 includes a deformation 96, for example a crimpor protrusion formed near the distal end of the needle 12. The opening94 in the washer 42 is sized to allow passage of the needle shaft, butnot the deformation 96. The funnel 92 makes it easier for the proximalend of the needle 12 to be initially inserted through the washer 42during assembly.

FIGS. 81-89 depict an alternative exemplary catheter hub 214 having apair of stabilization wings 216. FIGS. 90-103 depict another alternativeexemplary side port catheter hub 314 having a pair of stabilizationwings 316 and a side port 318. The side port communicates with aninternal tubular valve (not shown) as described in U.S. Pat. No.4,231,367, which is incorporated herein by reference. The alternativecatheter hubs 214, 314 each have a collar 234, 334 with an opening 236,336 to receive the latch 84 of the needle shield 20.

The catheter assemblies can include a plug 320 that is initiallyattached to the needle hub 16. After the needle hub 16 and needle shield20 have been removed from the catheter hub, the plug 320 can be removedfrom the needle hub 16 and attached to the open, proximal end of thecatheter hub. Although depicted with only the side port catheter 314,the plug 320 can be used with any of the catheter hubs 14, 214, 314.

FIGS. 104-112 depict the catheter assembly 10 of FIGS. 1-12 duringoperation. Initially, the needle shield 20 is connected to the catheterhub 14 and the introducer needle 12 passes through the catheter hub 14and the needle shield 20. The nose 48 of the needle shield 20 (labeledin FIG. 30) may or may not extend into the catheter hub 14 when theneedle 12 is in use (first position). The needle 12 cooperates with theclip 40 by biasing the clip 40 into a locked position via pressing thefirst and second arms 60, 62 toward one another. In the locked position,the latch 84 engages the collar 34, preventing removal of the needleshield 20 from the catheter hub 14, as best shown in FIG. 108. At thesame time, in the locked position, the latch 84 is offset from thecollar opening 36. The position of the latch 84 is off-center withrespect to the needle 12. The clip 40 is also in an open position,allowing the needle 12 to traverse through the clip 40.

As the needle 12 is withdrawn from the catheter hub 14 and into theneedle shield 20, the tip of the needle 12 clears the clip 40, and theclip 40 is allowed to resiliently expand, causing the second arm 62 tomove away from the first arm 60. As the clip 40 expands laterally, theprimary and secondary flags 78, 80 block the distal opening 44 of theouter housing 38 aperture, preventing the tip of the needle 12 fromexiting the distal end of the outer housing 38.

Movement of the second leg 62 moves the latch 84 laterally fromengagement with the collar 34 to a position aligned with the collaropening 36, allowing the needle shield 20 to be disengaged or unlockedfrom the catheter hub 14. The direction in which the latch 84 moves islateral with respect to a centerline of the needle 12. The latch 84movement is not radial toward or away from the needle 12. Moreover, asthe latch 84 is adjusted, the latch 84 moves to a centered position andthen ultimately moves off-center with respect to the needle 12. Theoff-center positions of the latch 84 in the first and second positionsof the needle 12 are symmetrically opposite each other.

In the position when the flags 78, 80 block the needle 12, the clip 4 omoves to a closed position. At the same time, the needle 12 enters intoa second position that is retracted from the first needle position,which prevents further use of the needle 12. The first position, asdescribed above, is understood as, for example, all positions of theneedle 12 prior to entering the second position.

As the needle 12 is pulled further in the proximal direction, the shaftof the needle 12 slides through the needle shield 20 until thedeformation 96 formed near the distal end of the needle 12 cooperateswith and engages the washer 42, as shown in FIG. 107. The opening in thewasher 42 is sized to allow passage of the needle shaft, but not thedeformation 96. Thus, the washer 42 prevents the distal tip of theneedle 12 and the deformation 96 from exiting the needle shield 20 whenthe needle 12 is in the second position. The combination of the washer42 and the needle shield 20 enclose or cover the distal tip of theneedle 12 in this second position. Further proximal movement of theneedle 12 results in the needle shield 20 being pulled away from thecatheter hub 14.

The combination of the clip 40 and the washer 42 act as an exemplaryneedle tip protection mechanism. This needle tip protection mechanismencloses or covers the distal needle tip and the deformation 96 andprevents these portions of the needle 12 from exiting the needle shield20.

More information regarding needle tip protection mechanisms of the typeused in this embodiment can be found in U.S. Pat. Nos. 6,749,588 and7,604,616, and U.S. Patent Application Publication No. 2014/0364809, thecontents of which are hereby incorporated by reference. The featuresdescribed in this embodiment, including the needle protection features,can be used in combination with the features described throughout thisapplication.

As depicted in FIGS. 113-116, the use of the clip 40 and the notchedcollar 34 allows for a smaller, more compact design. Without the collaropening 36, the latch 84 would have to move a distance B1 to clear thecollar and allow disengagement of the needle shield 20. With the collaropening 36, the latch 84 does not have to clear the entire catheter hub14 and only needs to move a distance B2 which is less than B1.

FIGS. 117 and 118 depict the use of the catheter valve actuator 28. Theintroducer needle 12 initially extends through the actuator 28, theseptum 26, the wedge 24, and the catheter tube 22. After the introducerneedle 12 and the catheter tube 22 are inserted into a patient, theneedle 12 is withdrawn, closing the septum 26. As a male Luer connector98 is inserted into the catheter hub 14, the Luer connector 98 abuts andmoves the actuator 28 in the distal direction, compressing the biasingmember 30. Further insertion of the Luer connector 98 moves the actuator28 through the septum 26, opening the slits and allowing fluid to flowthrough the catheter hub 14.

When the Luer connector 98 is removed, the biasing member 30 moves theactuator 28 in the opposite direction, removing it from the septum 26,closing the slits, and preventing fluid from flowing therethrough. Thisallows the catheter to be reused while in the patient's vein, as opposedto a single-use catheter where the actuator would remain in the septumafter a Luer connector 98 is removed. However, a single-use catheter canalso be used with the needle shield 20 described herein.

The actuator 28 has an actuator barrel 100 surrounding an internalpassage. The actuator barrel 100 is a substantially tubular member andthe internal passage is substantially cylindrical. A first end of theactuator barrel 100 has a nose with a chamfered outer surface to engagethe septum 26. The tubular member has one or more openings 102 to permitfluid flow through and around the actuator barrel 100. The actuator 28includes a rear portion for engaging a male Luer connector.

In a first exemplary embodiment shown in FIG. 117, the actuator 28includes first and second sets of openings 102 in the barrel with thefirst set of openings near the nose. Openings are also illustrated inthe actuator 28 of FIGS. 106-107. The rear portion of the actuator 28 ofFIG. 117 also includes a set of legs 104 extending from the barrel andconnected to a ring 106. The features described in this embodiment canbe used in combination with the features described throughout thisapplication.

In a second exemplary embodiment shown in FIGS. 119-121, the actuator28A includes a set of grooves 101A and a set of openings 102A. Thegrooves 101A extend from the nose toward the back of the actuator barrel100A. The openings 102A are positioned towards the rear of the barrel100A. When the actuator 28A extends through the septum 26, the grooves101A channel fluid to the openings 102A which remain on the proximalside of the septum 26. The grooves 101A may be positioned on the side ofthe openings 102A or directly in line with the openings 102A. The rearportion of the actuator includes a set of legs 104A extending from thebarrel. As illustrated in FIG. 121, a ring 106A may be connected to thelegs 104A to engage a Luer connector 98 or the Luer connector 98 maydirectly engage the legs 104A as illustrated in FIGS. 119 and 120. Thefeatures described in this embodiment can be used in combination withthe features described throughout this application.

In an exemplary embodiment, the biasing member 30 is a spring, forexample a helical compression spring with a distal end and a proximalend. The spring may be made from metal, plastic, an elastomer, oranother suitable resilient material. The distal end of the spring formsan interference fit with the inner surface of the catheter hub 14. Theinterference fit may be sufficient to retain the spring, even duringloading. The proximal end of the spring connects to the actuator 28. Thefeatures described in this embodiment can be used in combination withthe features described throughout this application.

FIGS. 122-126 depict various exemplary blood flashback features of thecatheter assembly. Flashback is the visibility of blood that confirmsthe entry of the needle tip into the vein. Primary flashback 400 is seenthrough the catheter tubing as blood travels into the open distal end ofthe hollow needle 12, out a notch or opening 402 (also visible in FIG.13) in the needle 12 near the needle tip, and up through the internalannular space between the needle 12 and the inside of the cathetertubing 22. The secondary flashback 404 is seen in the needle hub/grip 16when it comes out of the back of the needle 12 and enters a flashchamber in the needle hub/grip. Air is vented by the plug in the back ofthe needle hub/grip 16 by a porous membrane or micro grooves. Tertiaryflashback 406 is in the catheter hub 14 when the blood from the primaryflashback 400 flows into it and stops at the blood control septum 26.Air is vented by micro grooves in the periphery of the blood controlseptum 26. The features described in this embodiment can be used incombination with the features described throughout this application.

FIG. 127 illustrates the actuator of FIG. 121 in further detail. Theactuator 554 can be used in the catheter assemblies illustrated in FIG.117-120. The actuator 554 includes a nose 558 that reduces friction whenthe actuator 554 penetrates into a septum 538 of a catheter hubassembly. The actuator 554 further includes openings 555 that extendthrough the actuator 554 in a direction perpendicular to a centerline ofthe actuator 554. For example, the actuator 554 can include tworectangular shaped openings 555, although more or less are contemplated.

The actuator 554 also includes a plurality of grooves 557 that extendaxially along the distal portion of an outer surface of the actuator 554in a plane parallel to the centerline of the actuator 554. For example,four grooves 557, substantially radially equidistant from each other,can be present along an external surface of the distal portion of theactuator 554, although more or less grooves 557 are contemplated. Thegrooves 557 can be of varying depths into the actuator 554. The grooves557 are different from the openings 555 because the grooves 557 do notextend through the actuator 554.

The openings 555 and the grooves 557 advantageously provide increasedarea for the fluid to move inside the catheter hub assembly. Theincreased area advantageously allows for fluid flushing and to preventcoagulation of fluid in the proximal and distal ends of the septum.Additionally, the openings 555 and the plurality of grooves 557advantageously minimize the stagnation of fluid and allow for greatermixing. The grooves 57 further prevent the septum from sealing on anoutside surface of the actuator during operation. By not forming asealing interface, the fluid is permitted to leak through the septum viathe grooves 57 and provide additional flushing.

FIG. 128 illustrates the actuator 554 of FIG. 127 in the catheter hubassembly. Similar to the embodiments described above, the catheter hubassembly further includes a catheter hub 514, a septum 538 and a biasingmember 556. As illustrated, the openings 555 and the grooves 557 of theactuator 554 provide more area for fluid flow inside the catheter hub514, thus achieving the advantages described above.

FIGS. 129 and 130 illustrate the catheter hub assembly when the biasingmember 556 is compressed and the actuator 554 penetrates the septum 538.The catheter hub assembly may be configured such that the openings 555and/or the grooves 557 of the actuator 554 optionally penetrates theseptum 538. In this embodiment, the openings 555 in the actuator 554 donot penetrate the septum 538. However, the grooves 557 in the actuator554 penetrate the septum 538. This configuration allows for increasedfluid flow from the proximal end to the distal end of the septum 38through the grooves 557, in addition to the advantages described above.After operation of the catheter assembly is complete, the actuator 554is retracted from the septum 538 via the force exerted by the biasingmember 556. The catheter assembly is configured for multiple uses upondepression of the actuator 554. The features described in thisembodiment, including the actuator, can be used in combination with thefeatures described throughout this application.

FIG. 131 illustrates another embodiment of an actuator 664 in a catheterhub assembly. The catheter hub assembly includes a catheter hub 662having a side port 668. The side port 668 provides secondary access tothe fluid flow in the catheter hub 662. The intersection of the mainbore of the catheter hub 662 and the side port 668 includes a sleeve672. The sleeve 672 provides selective fluid communication between theside port 668 and the catheter hub 662. Specifically, when sufficientfluid pressure is applied through the side port 168, the sleeve 672compresses. The compression of the sleeve 672 allows for fluid to enterthe catheter hub 662. The catheter hub assembly further includes aseptum 670 and a biasing member 666 that provides tension to theactuator 664.

The actuator 664 includes a plurality of openings 665 that extendthrough the actuator 664 in a similar manner as described above. Theactuator 664 includes two rows of four openings 665 having differentsizes and similar spacing, although various quantities, sizes andspacing of the openings 665 are contemplated. As illustrated, theopenings 665 provide more area for fluid flow inside the catheter hub662, thus achieving similar advantages described above with respect toFIGS. 127-130.

FIGS. 132 and 133 illustrate the catheter hub assembly when the actuator664 penetrates the septum 670 and compresses the biasing member 666. Thecatheter hub assembly is configured such that the openings 665 of theactuator 664 optionally penetrate the septum 670. In this embodiment,the openings 665 in the actuator 664 do not penetrate the septum 670.This configuration allows for increased fluid flow between the side port668 and the catheter hub 662 at the proximal end of the septum 670, inaddition to the advantages described above. If the openings 665 in theactuator 664 penetrate the septum 670, increased mixing of fluid wouldalso take place at a distal end of the septum 670.

When operation of the catheter assembly is complete, the actuator 664 isretracted from the septum 670 via the force exerted by the biasingmember 666. The catheter assembly is configured for multiple uses upondepression of the actuator 664. The features described in thisembodiment, such as the actuator, can be used in combination with thefeatures described throughout this application.

In another exemplary embodiment, the collar of the catheter hub asdescribed above can be replaced by any other structure that defines anotch. For example, the collar may be a groove or a recess in thecatheter hub. Accordingly, the groove in the catheter hub can be used toengage and disengage a clip in a similar manner as described above. Thefeatures described in this embodiment can be used in combination withthe features described throughout this application.

The foregoing detailed description of the certain exemplary embodimentshas been provided for the purpose of explaining the principles of theinvention and its practical application, thereby enabling others skilledin the art to understand the invention for various embodiments and withvarious modifications as are suited to the particular use contemplated.This description is not necessarily intended to be exhaustive or tolimit the invention to the exemplary embodiments disclosed. Any of theembodiments and/or elements disclosed herein may be combined with oneanother to form various additional embodiments not specificallydisclosed. Accordingly, additional embodiments are possible and areintended to be encompassed within this specification and the scope ofthe appended claims. The specification describes specific examples toaccomplish a more general goal that may be accomplished in another way.

As used in this application, the terms “front,” “rear,” “upper,”“lower,” “upwardly,” “downwardly,” and other orientational descriptorsare intended to facilitate the description of the exemplary embodimentsof the present invention, and are not intended to limit the structure ofthe exemplary embodiments of the present invention to any particularposition or orientation. Terms of degree, such as “substantially” or“approximately” are understood by those of ordinary skill to refer toreasonable ranges outside of the given value, for example, generaltolerances associated with manufacturing, assembly, and use of thedescribed embodiments.

1.-39. (canceled)
 40. A catheter assembly comprising: a catheter; aneedle having a sharp distal tip; a catheter hub having the catheter; aneedle shield connected to the catheter hub when the needle is in afirst position; and a clip disposed in the needle shield that cooperateswith the needle; wherein the clip engages the catheter hub in the firstposition of the needle; the clip disengages the catheter hub when theneedle is retracted to a second position to cover at least a portion ofthe needle; the clip includes a spade that attaches the clip to theneedle shield; and an outer surface of the spade is exposed to anoutside of the catheter assembly.
 41. The catheter assembly of claim 40,wherein: the catheter hub includes a collar having a notch; and thenotch is disposed on the collar.
 42. The catheter assembly of claim 41,wherein a portion of the collar has an outer diameter greater than aportion of an outer diameter of the catheter hub adjacent to the collar.43. The catheter assembly of claim 41, wherein the notch of the collarhas an outer diameter substantially equal to or greater than a portionof an outer diameter of the catheter hub adjacent to the collar.
 44. Thecatheter assembly of claim 41, wherein the collar includes external Luerthreads.
 45. The catheter assembly of claim 40, wherein the firstposition of the needle biases the clip into an open position duringneedle use.
 46. The catheter assembly of claim 40, wherein the secondposition of the needle allows the clip to move to a closed position toblock the distal tip of the needle when the needle is retracted afterneedle use.
 47. The catheter assembly of claim 46, wherein the clipincludes one or more flags that block the distal tip of the needle inthe second position.
 48. The catheter assembly of claim 40, furthercomprising: a washer disposed in the needle shield that cooperates withthe needle; wherein the needle further includes a deformation; and thewasher prevents the distal tip of the needle and the deformation fromexiting the needle shield when the needle is in the second position. 49.The catheter assembly of claim 48, wherein: the clip and the washerenclose the distal tip of the needle when the needle is in the secondposition.
 50. The catheter assembly of claim 40, wherein: the spadeincludes one or more barbs; and the one or more barbs engage an innersurface of the needle shield.
 51. The catheter assembly of claim 41,wherein: the collar is disposed on a proximal end of the catheter hub;and the clip includes a latch that is configured to engage and disengagethe collar and the needle shield.
 52. The catheter assembly of claim 51,wherein: the clip includes two legs; and the latch is disposed betweenthe two legs.
 53. The catheter assembly of claim 51, wherein the latchis offset from the notch to engage the collar when the needle is in thefirst position.
 54. The catheter assembly of claim 51, wherein the latchis aligned with the notch to disengage the collar when the needle is inthe second position.
 55. The catheter assembly of claim 51, wherein thelatch moves laterally to disengage the collar.
 56. The catheter assemblyof claim 51, wherein the latch is off-center with respect to the needleat each of the engaged and disengaged position.
 57. The catheterassembly of claim 40, wherein the outer wall further includes a rib tostiffen and strengthen the clip.
 58. The catheter assembly of claim 40,wherein the spade includes an inner wall that is secured to the needleshield.
 59. The catheter assembly of claim 40, wherein: the spadeincludes an opening; the needle shield includes a barb; and the barbengages the opening in the spade to secure the clip to the needleshield.
 60. The catheter assembly of claim 40, wherein: the spadeincludes one or more barbs; and the one or more barbs engage at leastone of an inner surface and an outer surface of the needle shield. 61.The catheter assembly of claim 40, wherein: the clip includes two legs;and the spade is disposed between the two legs.
 62. The catheterassembly of claim 40, wherein: the clip includes two legs; and the spadeis disposed in an area outside the two legs.
 63. The catheter assemblyof claim 40, wherein: the clip includes two legs; and the spade isdisposed at a top surface of one of the two legs.
 64. The catheterassembly of claim 40, wherein: the clip includes three legs; and thespade is disposed at a bottom surface of one of the three legs.
 65. Thecatheter assembly of claim 40, wherein: the clip includes a rear wall,the rear wall being substantially perpendicular to a longitudinal axisof the catheter assembly; and the rear wall includes one or more barbsthat secure the clip to the needle shield.
 66. The catheter assembly ofclaim 40, wherein the clip includes one or more flags that block thedistal tip of the needle in the second position.
 67. The catheterassembly of claim 40, wherein: the clip includes a mounting cavity; theneedle shield includes a mounting protrusion; and the mounting cavityengages the mounting protrusion to secure the clip to the needle shield.68. A catheter assembly comprising: a catheter; a needle having a sharpdistal tip; a catheter hub housing the catheter; a needle shieldconnected to the catheter hub when the needle is in a first position;and a clip disposed in the needle shield that cooperates with theneedle, the clip including: a latch that is configured to engage anddisengage the collar and the needle shield; and two legs; wherein thelatch is disposed between the two legs; the clip engages the catheterhub in the first position of the needle; the clip disengages thecatheter hub when the needle is retracted to a second position to coverat least a portion of the needle; the clip includes a spade thatattaches the clip to the needle shield; and an outer surface of thespade is exposed to an outside of the catheter assembly.
 69. A catheterassembly comprising: a catheter; a needle having a sharp distal tip; acatheter hub housing the catheter; a needle shield connected to thecatheter hub when the needle is in a first position; and a clip disposedin the needle shield that cooperates with the needle; the clipincluding: a latch that is configured to engage and disengage the collarand the needle shield; and two legs; wherein: the latch is disposedoutside an area between the two legs; the clip engages the catheter hubin the first position of the needle; the clip disengages the catheterhub when the needle is retracted to a second position to cover at leasta portion of the needle; the clip includes a spade that attaches theclip to the needle shield; and an outer surface of the spade is exposedto an outside of the catheter assembly.
 70. The catheter assembly ofclaim 29, wherein the latch further includes a rib to stiffen andstrengthen the clip.
 71. The catheter assembly of claim 30, wherein thelatch further includes a rib to stiffen and strengthen the clip.
 72. Amethod of operating a catheter assembly, comprising: disposing a needlehaving a sharp distal tip in a catheter; attaching a clip to thecatheter assembly, the clip having a spade; exposing an outer surface ofthe spade to an outside of the catheter assembly; biasing the clip whenthe needle is in use in a first position; removing the needle from acatheter hub; releasing the clip when the needle is in a second positionto enclose at least a portion of the needle; and disengaging the clipfrom the catheter hub when the needle is in the second position.
 73. Themethod of claim 72, further comprising engaging the clip and thecatheter hub when the needle is in the first position.
 74. The method ofclaim 72, further comprising: connecting the catheter hub and a needleshield when the clip engages the catheter hub; and disconnecting thecatheter hub and the needle shield when the clip disengages the catheterhub; wherein the clip is disposed in the needle shield.